BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, 2 LEVEL; SIZE 42 MM

    MDR report key: 17667253 · Received August 31, 2023

    Report

    Report Number
    3004774118-2023-00106
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    August 10, 2023
    Report Date
    January 23, 2024
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    UDI-DI
    10888857401617
    PMA / PMN Number
    K172104
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3) WITH 2 VIALS OF TEST STRIPS (REFERENCE (B)(4)). DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-3 ERROR USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2024 AND TEST STRIPS WERE OPENED TWO DAYS BEFORE THE CALL. THE CUSTOMER REPORTED FEELING DIZZY; CUSTOMER STATED HE WAS GOING TO SEE HIS DOCTOR AFTER THE CALL DUE TO THE DIZZINESS. CUSTOMER IS INSULIN DEPENDENT BUT HE DID NOT SPECIFY IF HE BASED THE DOSAGE OF INSULIN ON HIS RESULTS.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS MIGRATED OZARK SCREWS AND AN OZARK PLATE WITH A DISENGAGED LOCKING MECHANISM. THIS REPORT CAPTURES THE OZARK PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514979 PLATE, 2 LEVEL; SIZE 42 MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ K2M, INC. UNKNOWN 10888857401617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention